FDA Finalizes FSVP Guidance for Importers of Human and Animal Food

On January 10, the FDA issued a final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. As our readers know, under the Food Safety Modernization Act (FSMA), FSVP requires that importers verify that the food which they import provides the same level of public health protection as the preventive controls or produce safety regulations (as appropriate) in the U.S. and to ensure that supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

The guidance is intended to assist importers in developing and implementing FSVP records, and following FSVP requirements for each food they import. The guidance includes recommendations on the requirements to analyze the hazards in food; how to evaluate a potential foreign supplier’s performance and the risk posed by the food; ways to determine and conduct appropriate foreign supplier verification activities; and how importers of dietary supplements or very small importers can meet modified FSVP requirements.

The guidance finalizes a 2018 draft guidance, and addresses comments received regarding what food the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform the FSVP activities.

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© 2023 Keller and Heckman LLP

Uyghur Forced Labor Prevention Act Is Coming… Are You Ready? CBP Issues Hints at the Wave of Enforcement To Come

US Customs and Border Protection (CBP) has issued some guidance relating to its enforcement of the Uyghur Forced Labor Prevention Act (UFLPA) prior to June 21, 2022, the effective date of the rebuttable presumption.

What to Know

  • US Customs and Border Protection (CBP) has issued some guidance relating to its enforcement of the Uyghur Forced Labor Prevention Act (UFLPA) prior to June 21, 2022, the effective date of the rebuttable presumption.
  • The new guidance imposes tighter timelines and a higher burden of evidence on importers to rebut the presumption that merchandise was produced with forced labor. If CBP does not make a decision within specific timeframes, goods will automatically be deemed excluded.
  • CBP is expected to issue additional technical guidance at the end of May or early June. The Department of Homeland Security (DHS) is also expected to issue guidance closer to June 21, 2022.
  • CBP is scheduled to host informational webinars detailing their UFLPA guidance in the coming weeks.

What’s New: Tighter Timelines  

While US importers were eagerly anticipating the issuance of technical guidance regarding implementation of the UFLPA from CBP last week, which is now expected this week, CBP did post a new guidance document summarizing the UFLPA and forced labor Withhold Release Orders (WRO) enforcement mechanisms. Specifically, CBP’s authority to detain merchandise under the UFLPA will be pursuant to 19 CFR § 151.16, which provides for a much different timeline for the detention of merchandise than the WRO process. Under this process, if Customs does not make a timely decision regarding admissibility, goods are automatically excluded.

UFLPA Timeline Enforcement under 19 CFR § 151.16

Number of Days

Actions

5 Days from Presentation for Examination

CBP must decide whether to release or detail merchandise

  • If the merchandise is not released, it is detained
5 Days after Decision to Release or Detain

CBP will issue a notice to importer advising them of:

  • The initiation of detention
  • Date merchandise examined
  • Reason for detention
  • Anticipated length of detention
  • Nature of tests and inquiries to be conducted
  • Information to accelerate disposition
  Upon written request, CBP must provide importer with testing procedures, methodologies used, and testing results
Within 30 Days of Examination

CBP will make a final determination as to the admissibility of merchandise

  • If CBP does not make a determination within the 30-day period, the merchandise will be deemed excluded
  • This means any submission to rebut the presumption should be made before this 30 day period
Within 180 Days of CBP Determination/Exclusion Importers may protest CBP’s final determination
Within 30 Days After Protest Submitted The protest is deemed denied if CBP does not grant or deny the protest within 30 days
Within 180 Days after the Date the Protest is Denied

The importer may commence a court action contesting the denied protest (28 U.S.C. § 1581(a))

  • In a court action, CBP must establish by a preponderance of the evidence that an admissibility decision has been reached for good cause
  • Customs can decide to grant the protest after the deemed denial but before a court case is filed

This is a much shorter timeline than the WRO process. Importantly, a company contesting CBP’s detention of merchandise pursuant to the UFLPA would be required to submit documentation to rebut the presumption within the 30-day period that CBP is assessing admissibility, whereas the WRO process permits 90 days. Like the WRO process, the importer may also file a protest 180 days after CBP makes its final determination regarding the exclusion.

CBP Listening Session: A Higher Burden of Evidence 

On Tuesday, May 24, 2022, CBP provided information regarding the publication of guidance and enforcement of the UFLPA:

  • CBP Publication of Guidance. CBP’s guidance regarding its enforcement of the rebuttable presumption and the UFLPA is scheduled to be published the week of May 30.
  • DHS Publication of Guidance. DHS guidance will be published on or about June 21, 2022, which will include information relating to supply chain due diligence, importer guidance, and the entity lists.
  • Clear and Convincing Evidence Required to Rebut the Presumption that Merchandise was Produced with Forced Labor. It was confirmed that the UFLPA will have a much higher burden of evidence required to rebut the presumption that merchandise was produced with forced labor than that of a WRO. Any exception to the rebuttable presumption must be reported to Congress, and thus the level of evidence that will be required to overcome the rebuttable presumption is very high. As a practical matter, it appears that very few detained entries will be released. Importers are advised to start conducting due diligence on supply chains in order to ensure that they will be able to obtain documentation should merchandise be detained once the rebuttable presumption goes into effect. Importantly, products that are subject to an existing WRO from Xinjiang will now be enforced under the UFLPA process instead of the WRO process.
  • Evidence Required if Merchandise is Detained. The forthcoming guidance will set forth information regarding how an importer may meet the exception to the rebuttable presumption and to demonstrate that merchandise was not produced with forced labor, by meeting the following three criteria:
    • Demonstrate compliance with the Forced Labor Enforcement Task Force/DHS strategy;
    • Demonstrate compliance with CBP’s guidance and any inquiries that CBP raises; and
    • Provide clear and convincing evidence that the supply chain in question is free of forced labor.
  • Binding Rulings. Importers may apply for a binding ruling to confirm or request an exception to the rebuttable presumption under the UFLPA. Although CBP is still finalizing the process for importers to apply for a binding ruling, importers would be required to prove by clear and convincing evidence that merchandise is not produced with forced labor. If the ruling is granted, it applies to future shipments for the specific supply chain in question.
  • Known Importer Letters and Detention Notices. Going forward, CBP will not issue Known Importer letters, and CBP will notify importers that merchandise is subject to the UFLPA through the issuance of detention notices.
  • Detention of Merchandise. If goods are detained by CBP because they are suspected of having a nexus to Xinjiang Uyghur Autonomous Region (XUAR) of the People’s Republic of China (PRC), importers may either provide clear and convincing evidence that merchandise was not produced with forced labor or export the products. If detained products that fall under the UFLPA are comingled with other products that are not subject to the UFLPA, importers may request the segregation of the merchandise that is not subject to the UFLPA.
  • Chain of CBP Review for Importer Submissions Relating to Detained Merchandise. Chain of CBP review for the request of an exception to the rebuttable presumption has not been finalized yet. However, importers will be required to submit evidence that rebuts the presumption that merchandise was produced with forced labor to the applicable CBP Port Director. For the moment, the CBP Commissioner is the final individual who can ultimately make an exception to the rebuttable presumption, but CBP is deciding if it will delegate this responsibility to any additional persons.

Upcoming CBP Informational Webinars

CBP will be holding three webinar sessions, all covering the same material, to discuss and review its guidance relating to the UFLPA. The dates of the webinars and the registration links are listed below.

© 2022 ArentFox Schiff LLP

World Trade Organization Approves U.S. Tariffs on European Union Goods to Counteract Civil Aviation Subsidies

The World Trade Organization (WTO) has approved U.S. duties on $7.5 billion in products from the European Union (EU) after ruling that the EU had unfairly subsidized the production of large civil aircraft, such as those produced by Airbus. The U.S. Trade Representative (USTR) will enforce 10 percent duties on imports of certain aircraft and 25 percent duties on imports of other goods (including agricultural products, apparel, machinery, and other products) beginning October 18, 2019.

The EU plans to impose retaliatory tariffs on $20 billion of U.S. exports in response to subsidies allegedly provided to American plane manufacturer Boeing. However, the EU will have to wait for WTO approval in separate proceedings. The United States and the EU have been involved in WTO dispute settlement proceedings regarding subsidies for large civil aircraft since 2004.

Duties of 10 percent apply to imports of passenger and cargo aircraft from France, Germany, Spain, and the United Kingdom (where the majority of Airbus production is based), provided that they have an unladen weight exceeding 30,000 kg.1

Duties of 25 percent apply to imports of other products from all EU member states (or a subset of these member states, depending on the product category). These products include certain cheeses, pork, coffee, seafood, fruit, dairy spreads, wine, whisky, apparel, bedding, optical instruments, appliances, tools, folding knives, and magnets.

Military aircraft, civil helicopters, and parts or components of civil aircraft are not subject to the duties.2


1 Examples of subject aircraft over 30,000 kg are regional jets capable of seating more than 100 passengers (such as the Airbus A220) and any larger aircraft (including long-haul, wide-body jets). Smaller aircraft, including recreational aircraft, private jets, most turboprop aircraft, and most regional jets with a capacity of fewer than 100 passenger, have an unladen weight of less than 30,000 kg and are excluded.

2 Airbus has production facilities in the United States, that rely on components imported from the EU. Additionally, some EU companies produce certain components of military aircraft for export to the United States.


©2019 Drinker Biddle & Reath LLP. All Rights Reserved

For more on international trade, see the National Law Review Antitrust & Trade Regulation or Global law pages.

White House Issues Presidential Proclamations Imposing Section 232 Tariffs on Steel and Aluminum Imports

President Trump, on March 8, 2018, issued two presidential proclamations imposing global tariffs of 25 percent on steel imports and 10 percent on aluminum imports in connection with the Section 232 investigations recently concluded by the Department of Commerce. The effective date of the tariffs for both Section 232 actions is March 23, 2018; their duration has not been specified at this time.

Steel

Product Scope

The presidential proclamation covers steel imports entered under HTSUS 7206.10 through 7216.50, 7216.99 through 7301.10, 7302.10, 7302.40 through 7302.90, and 7304.10 through 7306.90, including any subsequent revisions to these HTS classifications.

Remedy

This trade action imposes a 25 percent tariff on steel imports from all countries, with the exception of Canada and Mexico.

Aluminum

Product Scope

The presidential proclamation covers the following aluminum imports: (a) unwrought aluminum (HTS 7601); (b) aluminum bars, rods, and profiles (HTS 7604); (c) aluminum wire (HTS 7605); (d) aluminum plate, sheet, strip, and foil (flat rolled products) (HTS 7606 and 7607); (e) aluminum tubes and pipes and tube and pipe fitting (HTS 7608 and 7609); and (f) aluminum castings and forgings (HTS 7616.99.51.60 and 7616.99.51.70), including any subsequent revisions to these HTS classifications.

Remedy

This trade action imposes a 10 percent tariff on aluminum imports from all countries, with the exception of Canada and Mexico.

Product Exclusions

There will also be a mechanism for U.S. parties to apply for the exclusion of specific products based on unmet demand or specific national security considerations. The Secretary of Commerce shall issue procedures for exclusion requests within 10 days of March 8, 2018.

Country Exclusions

Canada and Mexico will be temporarily exempt from these measures due to their security relationship with the United States. Other countries may be able to qualify for a modification or removal of the tariffs if they come up with “alternate ways to address the threatened impairment of national security caused by imports.” The United States Trade Representative will be responsible for negotiations regarding such alternative arrangements. According to a White House official, the tariff rate for other countries may increase if Canada and Mexico secure a permanent exemption.

 

©2018 Drinker Biddle & Reath LLP. All Rights Reserved
This post was written by Nate BolinDouglas J. Heffner and Richard P. Ferrin of Drinker Biddle.
Check out the National Law Review’s Global Page for more insights.